MOD-4023
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 78 | 下垂体前葉機能低下症 | 35 |
78. 下垂体前葉機能低下症
臨床試験数 : 492 / 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100
Showing 1 to 10 of 35 trials
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-183963 | 25/12/201720171225 | 17/05/201820180517 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-40 ... | Treatment of children with growth failure due to growth hormone deficiency (GHD) | Intervention name : Somatrogon (Genetical Recombination) INN of the intervention : somatrogon Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. Control intervention name : Genotropin INN of the control intervention : somatropin Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day). Intervention name : Somatrogon (Genetical Recombination) INN of the intervention : somatrogon Dosage A ... | OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd) | NULL | complete | 3 | 11 | BOTH | 44 | Phase 3 | Japan |
| 2 | EUCTR2016-003874-42-GR (EUCTR) | 20/12/201720171220 | 21/11/201720171121 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency An efficacy and safety study of weekly mod-4023compared to daily genotropin® therapy in pre-pubertal ... | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4 ... | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification cod ... | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Soma ... | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United K ... | ||
| 3 | NCT03874013 (ClinicalTrials.gov) | December 7, 201720171207 | 1/10/201820181001 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone Deficiency A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-40 ... | Growth Hormone Deficiency | Drug: MOD-4023;Drug: Genotropin | OPKO Health, Inc. | NULL | Completed | 3 Years | 11 Years | All | 44 | Phase 3 | Japan |
| 4 | EUCTR2016-003874-42-GB (EUCTR) | 04/09/201720170904 | 03/01/201720170103 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency An efficacy and safety study of weekly mod-4023compared to daily genotropin® therapy in pre-pubertal ... | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4 ... | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification cod ... | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Soma ... | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand;United States;Belarus Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Me ... | ||
| 5 | EUCTR2016-003874-42-DE (EUCTR) | 04/08/201720170804 | 01/02/201720170201 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency An efficacy and safety study of weekly mod-4023compared to daily genotropin® therapy in pre-pubertal ... | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4 ... | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification cod ... | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Soma ... | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;It ... | ||
| 6 | EUCTR2016-003874-42-IT (EUCTR) | 16/06/201720170616 | 06/09/202120210906 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency An efficacy and safety study of weekly mod-4023compared to daily genotropin® therapy in pre-pubertal ... | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4 ... | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification cod ... | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Soma ... | PRM|21097 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | France;Greece;Spain;Poland;Bulgaria;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2016-003874-42-ES (EUCTR) | 18/05/201720170518 | 14/03/201720170314 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency An efficacy and safety study of weekly mod-4023compared to daily genotropin® therapy in pre-pubertal ... | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4 ... | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification cod ... | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Soma ... | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;It ... | ||
| 8 | EUCTR2016-003874-42-BG (EUCTR) | 26/04/201720170426 | 13/02/201720170213 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency An efficacy and safety study of weekly mod-4023compared to daily genotropin® therapy in pre-pubertal ... | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4 ... | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification cod ... | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Soma ... | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United K ... | ||
| 9 | NCT02968004 (ClinicalTrials.gov) | December 201620161200 | 13/11/201620161113 | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children ... | A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4 ... | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | OPKO Health, Inc. | NULL | Active, not recruiting | 3 Years | 11 Years | All | 224 | Phase 3 | United States;Argentina;Australia;Belarus;Bulgaria;Canada;Colombia;Georgia;Greece;India;Israel;Korea, Republic of;Mexico;New Zealand;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;Germany;Italy;Turkey United States;Argentina;Australia;Belarus;Bulgaria;Canada;Colombia;Georgia;Greece;India;Israel;Korea ... |
| 10 | NCT02418767 (ClinicalTrials.gov) | January 201520150100 | 8/1/201520150108 | Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) i ... | A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Single Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Doses of Long Acting HGH Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Single Dose Trial to Evaluate the Sa ... | Growth Hormone Deficiency | Drug: MOD-4023;Drug: Placebo | OPKO Health, Inc. | WCCT Global | Completed | 18 Years | 45 Years | Male | 42 | Phase 1 | United States |